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Acceptace criteria for interlaboratory metod transfer

Posted: Mon Feb 11, 2019 12:14 pm
by Mihaela Cristea
Hello everyone,
I am looking for some acceptance criteria for interlaboratory non-statistical comparison for related substances method transfer for film coated tablets. Can you, please, advice me? Is there any guideline related to this topic?
Thank You!

Re: Acceptace criteria for interlaboratory metod transfer

Posted: Mon Feb 11, 2019 6:29 pm
by Consumer Products Guy
1. We did such cGMP transfers to our QC and to contract manufacturers' QC several times a year.

2. Unfortunately, I cannot remember what our agreement values were for agreement to R&D values, or where the values came from.

Obviously, results had to meet cGMP system suitability criteria. This held for EACH OPERATOR at these locations. We supplied three samples previously assayed at R&D; each sample would be prepared from scratch three times, and each prepared sample was injected at least twice.

I think we used 98 – 102% agreement and standard deviation of 2 for each of the nine samples.